NCT00171613

Brief Summary

The extension protocol is designed to allow those patients randomized to placebo in the core portion of the protocol to receive a 6 month treatment of open label octreotide and allow those patients randomized to octreotide who appeared to benefit from treatment, to continue to receive octreotide.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

September 13, 2005

Last Update Submit

April 27, 2012

Conditions

Hypothalamic Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in BMI

Secondary Outcomes (1)

  • Change from baseline in weight, leptin, insulin AUC, C-peptide AUC, amylin AUC, glucose AUC, dietary intake, physical activity, waist-to-hip ratio, visceral and subcutaneous abdominal fat

Interventions

OctreotideDRUG

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Patient must provide written informed consent

You may not qualify if:

  • Any patient that experienced unresolved safety complications at any time during the original protocol CSMS995B2403
  • Patients with a history of gallstones or any patient developing gallstones during the course of the core protocol
  • Patients for whom there are safety or tolerability concerns for continuing Octreotide Depot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sexual InfantilismObesity

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Gonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System DiseasesHypogonadismOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Novartis

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

February 1, 2005

Primary Completion

October 1, 2005

Last Updated

April 30, 2012

Record last verified: 2012-04